Long-term Study to Evaluate Safety and Persistence of GF-CART01
A Long-term Follow-up Study of GF-01-01 to Evaluate the Safety and Persistence of GF-CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies
1 other identifier
observational
18
1 country
1
Brief Summary
The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2025
CompletedFirst Posted
Study publicly available on registry
May 22, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2041
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2041
December 18, 2025
December 1, 2025
15 years
May 15, 2025
December 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Long-Term Safety of GF-CART01 after infusion
Percentage of subjects with ≥ grade 3 GF-CART01-related adverse events, serious adverse events (SAEs), adverse events of special interest (AESIs)
up to 15 years after GF-CART01 infusion
Secondary Outcomes (2)
GF-CART01 persistence
up to 15 years after GF-CART01 infusion
Efficacy of GF-CART01
up to 15 years after GF-CART01 infusion
Study Arms (1)
LTFU
Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are invited to participate in this follow-up study.
Eligibility Criteria
Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are eligible to participate in this follow-up study. The study may allow for a maximum enrollment of 18 subjects.
You may qualify if:
- Subjects previously enrolled in the study of GF-CART01 (Protocol No.: GF-01-01) and received GF-CART01 infusion
- Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent
- Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Biospecimen
whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
n
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2025
First Posted
May 22, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2041
Study Completion (Estimated)
May 1, 2041
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share